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FDA to Cooperate with Five European Countries on Generic Drug Application Inspections

Friday, December 20, 2013

Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration and the European Medicines Agency announced Dec. 18 the launch of an initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. These studies must demonstrate scientifically that a generic drug performs in the same manner as the brand name drug, an FDA press release states, and the FDA and European Union regulatory authorities inspect facilities that conduct these studies to ensure that data submitted to the agencies are reliable. The new effort, which involves EU member states France, Germany, Italy, the Netherlands and the United Kingdom and will begin with an 18-month pilot phase, provides a mechanism to conduct joint facility inspections around the world.